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Stockreport

FDA Accepts Biologics License Application for Filing and Grants Priority Review for Sacituzumab Govitecan for the Treatment of Metastatic Triple-negative Breast Cancer

IMMUNOMEDICS (IMMU)  More Company Research Source: GlobeNewswire
Last immunomedics earnings: 8/23 04:00 pm Check Earnings Report
PDF MORRIS PLAINS, N.J., July 18, 2018 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for filing and granted Priority Review for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. The PDUFA target action date is January 18, 2019. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC. “We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review,” commented Michael Pehl, President and Chief Executive Officer. “We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC p [Read more]

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